BS120/200

4 x 30/2 x 16 mL
UREA U V 12005024

Interferences
Intended Use
No interference for
This reagent is intended for in vitro quantitative determination of urea in serum,
plasma & urine. Bilirubin up to 20 mg/dL
-Urease / GLDH methodology Ascorbic acid up to 50 mg/dL
-Linear up to 300 mg/dL Haemoglobin up to 1000 mg/dL

Clinical Significance Materials provided

Proteins cannot be stored in human body, so excess should be broken down. Amino Urea U V R1 & R2 Reagent
acids which form the components of proteins break down to give ammonia. This is
Reagents required but not provided
toxic & so through a series of chemical reactions (urea cycle) non toxic urea is
Multicalibrator (Product Code: 11610002), Qual icheck Norm (Product Code:
produced & this is released into the blood which is filtered in the kidney & excreted
11601003), Qualicheck Path ( Product Code: 11601002)
in the urine.
Elevated levels are seen during increased protein breakdown, dehydration, vomiting, Unit Conversion
and d iarrhea. Also seen in any kind of renal disorder like Glomerular nephritis, Conversion from
chronic nephritis & nephritic syndrome. Trad itional Unit SI Unit
Trad itional to SI
Principle mg/dL mmol/L x 0.1665

urease Calibration
Urea + H 2O ——————————> 2NH3 + CO2 Agappe Multicalibrator (Product Code: 11610002) is recommended for calibration
of the assay.
GLDH
2NH 4+ 2α -ketoglutarate + 2NADH ————> 2L-Glutamate + 2NAD+ 2H2 O
Quality Control
Kit Components It is recommended to use Qualicheck Norm (Product Code: 11601003) or Qualicheck
Path (Product Code: 11601002) to verify the performance of the measurement
Reagent/ Product Code Description procedure.
Component 12005024
Each Laboratory has to establish its own internal quality control scheme and
Urea U V R1 4 x 30 mL Buffer (pH 7.6) 100 mmol/L procedures for corrective action if controls do not recover within the acceptable
ADP 0.7 mmol/L tolerance.
α-ketoglutarate 9.0 mmol/L
GLDH >1100 U/L Reference Range
Urease >6500 U/L It is recommended that each laboratory should establish its own reference values.
Urea U V R2 2 x 16 mL NADH 0.25 mmol/L The fol lowing value may be used as guide line.
2-Oxoglutarate 5 mmol/L Serum/Plasma : 10-50 mg/dL
Urine : 20-35 gm/24 hr
Risk & Safety
Results obtained for patient samples are to be correlated with clinical findings of
Material Safety data sheets (MSDS) wil l be provided on request
patient for interpretation and diagnosis.
Reagent Preparation
Performance
Urea U V R1 & R2 Reagents are ready to use.
1. Linearity
Reagent Storage and Stabil ity The reagent is linear up to 300 mg/dL. If the concentration is greater than linearity
The sealed reagents are stable upto the expiry date stated on the label, when stored (300 mg/dL), d ilute the sample with normal saline and repeat the assay. Multiply
at 2-8 OC. the result with dilution factor.
2. Comparison
Open Vial Stability A comparison study has been performed between Agappe reagent and another
Once opened the reagents are stable up to 30 days if contamination is avoided. internationally available reagent yielded a correlation coefficient of r2 = 0.9828 and
On-board Cal ibration Stability a regression equation of y = 0.9706x.
Calibration is stable for 20 days. 3. Precision
Intra Run Inter Run
Reagent Deterioration
Control Level 1 Level 2 Level 1 Level 2
Turbidity or precipitation in any kit component indicates deterioration and the
n 20 20 20 20
component must be discarded. Values outside the recommended acceptable range
for the Agappe Qualicheck Norm & Path control may also be an ind ication of Mean (mg/dL) 36 96 35.8 96.1
reagent instabil ity and associated results are invalid. Sample should be retested SD 1.2 2.0 1.0 2.4
using fresh vial of reagent. CV(%) 3.3 2.08 2.7 2.4

Precaution
To avoid contamination, use clean laboratory wares. Close reagent bottles Accuracy (mg/dL)
immed iately after use. Avoid direct exposure of reagent to light. Do not blow into Control Expected Value Measured Value
the reagent bottles. Control Level 1 32.6 ± 9.8 33
This reagent is only for IVD use and fol low the normal precautions required for
Control Level 2 102 ± 23 105
hand ling al l laboratory reagents.
Waste Management Qualicheck Norm 40 ± 8.42 42
Reagents must be disposed off in accordance with local regulations. Qualicheck Path 126 ± 18 128
Sample
4. Sensitivity
Serum,Plasma (Do not use l ipemic or hemolysed sample) - Do not use
Lower detection Limit is 1 mg/dL
anticoagulants containing fluorides and ammonium ions.
Bibliography
Urine - Diluted to 1/100 with distil led water. Multiply the result with dilution factor.
1. Tal ke, H. and Schubert G.E.Kiln-Wocchsr 43: 174 (1965)
2. Kassirer,J.P.,New Eng. J.Med. 285,385 (1971)
SYMBOLS USED ON THE LABELS

IN VITRO DIAGNOSTIC USE SEE PACKAGE INSERT FOR PROCEDURE LOT NUMBER MANUFACTURER’S ADDRESS MANUFACTURING DATE EXPIRY DATE TEMPERATURE LIMIT

AGAPPE DIAGNOSTICS LTD.

‘Agappe Hills’, Dist. Ernakulam, Kerala, India-683 562.
Tel. +91 484 2867 000 | Customer Support No.: 1800 425 7151(Toll Free) ISO 9001:2015
customersupport@agappe.in | www.agappe.com REV. NO.: ADL/IFU/UUV/BS1/R01 EN ISO 13485:2016
 BS120/200
4 x 30/2 x 16 mL
UREA U V 12005024

Parameters Screen Calibration Screen

Test UREA Rule Two Point Linear
No Sensitivity
Ful l Name Urea UV Replicates 1
Standard No. 2 Interval ( day) 0
Reaction Type Fixed time Difference Limit
Primary WL 340 SD
Sec. WL Blank Response
Direction Decrease Error Limit
Reaction Time 3 7 Determination Coeff. 0
Incubation Time 6 QC Screen
Unit mg/dL Control 1
Precision 0.1 Control 2
R1 200 µL
R2 50 µL
Sample 3 µL
R1 Blank 0 10000
Mixed Rgt.Blank 10000 25000
Linearity Range 0 300
Linearity Limit
Substrate Limit 8000
Factor
Prozone chek
q1 q2 q3 q4
PC Abs
Reference Screen
Low
High

SYMBOLS USED ON THE LABELS

IN VITRO DIAGNOSTIC USE SEE PACKAGE INSERT FOR PROCEDURE LOT NUMBER MANUFACTURER’S ADDRESS MANUFACTURING DATE EXPIRY DATE TEMPERATURE LIMIT

AGAPPE DIAGNOSTICS LTD.

‘Agappe Hills’, Dist. Ernakulam, Kerala, India-683 562.
Tel. +91 484 2867 000 | Customer Support No.: 1800 425 7151(Toll Free) ISO 9001:2015
customersupport@agappe.in | www.agappe.com REV. NO.: ADL/IFU/UUV/BS1/R01 EN ISO 13485:2016